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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00191698




Registration number
NCT00191698
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
31/10/2008

Titles & IDs
Public title
Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD
Scientific title
A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder
Secondary ID [1] 0 0
B4Z-MC-LYBX
Secondary ID [2] 0 0
7068
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 0 0
Oppositional Defiant Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - atomoxetine hydrochloride
Treatment: Drugs - placebo

Experimental: A - Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year

Placebo Comparator: B - Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year


Treatment: Drugs: atomoxetine hydrochloride


Treatment: Drugs: placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo
Timepoint [1] 0 0
over 8 weeks
Secondary outcome [1] 0 0
Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo
Timepoint [1] 0 0
over 8 weeks
Secondary outcome [2] 0 0
Mean change in ratings on the Oppositional subscale of the SNAP-IV
Timepoint [2] 0 0
over 8 weeks
Secondary outcome [3] 0 0
Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day.
Timepoint [3] 0 0
over 4 weeks
Secondary outcome [4] 0 0
Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).
Timepoint [4] 0 0
over 8 weeks
Secondary outcome [5] 0 0
Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).
Timepoint [5] 0 0
over 8 weeks
Secondary outcome [6] 0 0
Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).
Timepoint [6] 0 0
8 weeks, 12 weeks
Secondary outcome [7] 0 0
Adverse events (AEs)
Timepoint [7] 0 0
over 1 year

Eligibility
Key inclusion criteria
- Patients are male or female outpatients who are at least 6 years of age and not more
than 12 years of age at study entry.

- Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.

- If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be
the patient's primary diagnosis.

- Patients must have laboratory results, including serum chemistries, hematology, and
urinalysis showing no significant abnormalities.

- Patients must have an ECG performed at study entry that is absent of any abnormality
that, in the opinion of the physician, should exclude the patient.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients who weigh less than 20 kg or greater than 60 kg at study entry.

- Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive
developmental disorder.

- Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or
without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry.

- Patients with a history of any seizure disorder.

- Patients determined by the investigator to be at serious suicidal risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wallsend
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Parkville
Recruitment postcode(s) [1] 0 0
2287 - Wallsend
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Denmark
State/province [4] 0 0
Risskov
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
Germany
State/province [6] 0 0
Mannheim
Country [7] 0 0
Germany
State/province [7] 0 0
Ulm
Country [8] 0 0
Netherlands
State/province [8] 0 0
Nijmegen
Country [9] 0 0
Netherlands
State/province [9] 0 0
Utrecht
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Navarra
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Augus
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of
ODD in children with ADHD and ODD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00191698
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00191698